US20110034954A1 - Sutureless reinforcement for and method of treating a myocardial infarction - Google Patents
Sutureless reinforcement for and method of treating a myocardial infarction Download PDFInfo
- Publication number
- US20110034954A1 US20110034954A1 US12/908,662 US90866210A US2011034954A1 US 20110034954 A1 US20110034954 A1 US 20110034954A1 US 90866210 A US90866210 A US 90866210A US 2011034954 A1 US2011034954 A1 US 2011034954A1
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- sealant
- myocardial infarction
- reinforcement
- patch
- component
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2481—Devices outside the heart wall, e.g. bags, strips or bands
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00495—Surgical glue applicators for two-component glue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2481—Devices outside the heart wall, e.g. bags, strips or bands
- A61F2002/2484—Delivery devices therefor
Definitions
- the invention relates generally to medical apparatus and methods and more specifically, to reinforcements for myocardial infarctions and methods of forming such reinforcements.
- a myocardial infarction is the irreversible damage done to a segment of heart muscle by ischemia, where the myocardium is deprived of adequate oxygen and metabolite removal due to an interruption in blood supply. Ischemia is usually due to a sudden thrombotic occlusion of a coronary artery, commonly called a heart attack.
- the coronary artery becomes completely occluded and there is poor collateral blood flow to the affected area, an infarction can result.
- the resulting infarction will be a transmural or full-wall thickness infarct in which much of the contractile function of the area is lost.
- the necrotic tissue heals, leaving a scar.
- the most extreme example of this is a ventricular aneurysm where all of the muscle fibers in the area are destroyed and replaced by fibrous scar tissue.
- cardiac disorders e.g., heart remodeling such as ventricular remodeling or ventricular rupture
- electrical cardiac disorders e.g., congestive heart failure where cardiac output falls below a level adequate to meet the metabolic needs of the body which, if uncompensated, leads to rapid death.
- the damaged heart tissue may begin a long slow process of thinning and localized remodeling. Since the myocardial tissue is damaged and usually inadequately perfused, the damaged tissue contributes less to overall heart function compared to when the tissue was undamaged. The localized remodeling tends to place a greater demand on the rest of the heart to compensate for the reduced contractile capability of the damaged tissue. As a result, global heart function may be affected and, ultimately, the patient may experience global heart remodeling and descend into heart failure.
- Such patches or substrates are implanted via highly invasive open chest procedures and are sutured or stapled to the infarct tissue or tissue adjacent to the infarct.
- Highly invasive open chest procedures significantly increase patient risk and recovery time.
- infarct tissue or tissue adjacent to the infarct is often too fragile to receive sutures or staples.
- the invention relates to methods of treating myocardial infarction.
- One such method includes assembling a myocardial infarction reinforcement at a location of a myocardial infarction in a patient.
- Another method of treating myocardial infarction includes impregnating a patch with a first sealant component; delivering the patch to a myocardial infarction via an introducer extending through a percutaneous puncture in a subxiphoid region of a patient; and delivering a second sealant component to the myocardial infarction via the introducer extending through the percutaneous puncture in the subxiphoid region, wherein the first and second components combine to form a medical sealant material that bonds the patch to the myocardial infarction, thereby forming a reinforcement for the myocardial infarction.
- Yet another method of treating myocardial infarction includes dispensing first and second sealant components to a myocardial infarction via an introducer extending through a percutaneous puncture in a subxiphoid region, the first and second sealant components combine to form a medical sealant material that bonds to the myocardial infarction to form a reinforcement for the myocardial infarction, wherein the reinforcement does not include a patch.
- the invention also relates to myocardial infarction reinforcements.
- One such reinforcement includes a patch and medical sealant material.
- the patch includes a sheet having pores/voids.
- the patch extends over a myocardial infarction.
- the medical sealant material impregnates the pores/voids and bonds the patch to the myocardial infarction.
- Another reinforcement includes a medical sealant material extending over and bonding to a myocardial infarction to form the reinforcement.
- FIG. 1 is a plan view of a patch used to form a myocardial infarction reinforcement.
- FIG. 2 is a cross section of the patch as taken along section line 2 - 2 in FIG. 1 .
- FIG. 3 is a diagrammatic plan view of a patient with the chest open to reveal the patch being located intrapericardially via an introducer extending through a percutaneous puncture in the subxiphoid region.
- FIGS. 4-7 are diagrammatic views of the patch at various stages of its deployment via the introducer.
- FIG. 8 is a cross section view of the patch as taken along section line 2 - 2 in FIG. 2 , except the patch is deployed in the intrapericardial space and adhered to the epicardial surface via the sealant to form the reinforcement of the myocardial infarction.
- FIG. 9 is a perspective view of a patch in a non-deployed state being passed through a lumen of an introducer.
- FIG. 10 is the same view depicted in FIG. 9 , except the patch has biased into the expanded or deployed state and is being maneuvered into place over a myocardial infarction via a stylet distal end.
- FIG. 11 is the same view depicted in FIGS. 4-7 , except sealant is being applied prior to the deployment of the patch to the myocardial infarction 4 .
- FIG. 12 is the same view as FIGS. 4-7 , except the sealant is being applied subsequent to the deployment of the patch to the myocardial infarction.
- FIGS. 13 and 14 are views similar to FIGS. 11 and 12 , except illustrating a creation of a myocardial infarction reinforcement that does not employ a patch.
- the present application describes suture-free/staple-free reinforcements for, and methods of, treating a myocardial infarction that is leading to, or already has lead to, ventricular remodel or rupture.
- the reinforcements can be delivered and the treatment method can be performed by open chest procedures or, advantageously, by minimally invasive procedures such as accessing the intrapericardial space surrounding the heart via a puncture in the pericardial sac and a percutaneous puncture in the subxiphoid region of a patient.
- the reinforcement is one or more layers of medical adhesive and/or sealant material (generically referred to in the rest of this Detailed Description as medical sealant material) directly applied to the epicardial surface of a myocardial infarction.
- the reinforcement is a patch adhered to the epicardial surface of a myocardial infarction via the sealant material.
- the sealant material can impregnate the patch and/or be applied prior to, during, and/or subsequent to the patch being located over the myocardial infarction.
- the reinforcement adheres to and reinforces the myocardial infarction without the use of sutures or staples.
- the reinforcement can be said to be formed, assembled or created in the patient at the location of the myocardial infarction.
- the patch 22 includes a frame 26 and a mesh or porous sheet 24 extending between sides or sections of the frame 26 .
- the patch 22 will not include a frame 26 , but will simply be the sheet 24 .
- the sheet 24 may be attached to one side of the frame 26 .
- the sheet 24 extends about the frame 26 (e.g., the frame 26 is received in a seam of the sheet 24 ).
- the size of the sheet 24 may be generally the same as the size of the frame 26 or it may exceed the size of the frame 26 such that the edge of the sheet 24 extends past the frame 26 .
- Sizes of the patch 22 in their respective deployed, flattened states vary depending on the size of the heart 7 and the size of the infarcted area 4 .
- the patch 22 in its deployed, flattened state is at least approximately four millimeters by at least approximately seven millimeters.
- the patch 22 in its deployed, flattened state has a diameter of between approximately five millimeters and approximately eight millimeters.
- the patch 22 it its deployed, flattened state has a thickness of between approximately 0.2 millimeters and approximately 0.5 millimeters, while in another configuration it has a thickness of between approximately 0.1 millimeters and approximately 2 millimeters.
- the patch 22 in its deployed, flattened state is preferably at least approximately the same size as the area of the myocardial infarction. In one embodiment, the patch 22 in its deployed, flattened state has a size that exceeds the size of the area of the myocardial infarction by approximately zero percent to approximately 20 percent or more.
- the sheet 24 is fixed to the frame 26 via molding, gluing, suturing, or welding (e.g., sonic, chemical, heat, laser, etc.).
- the frame 26 may be formed of Nitinol, polytetrafluoroethylene (“PTFE”), silicone rubber, polyurethane, etc.
- the sheet 24 may be formed of a mesh or porous biocompatible natural material (e.g., a sheet of pericardium, etc.) or a mesh or porous biocompatible synthetic material (e.g., DACRON®, polyester, polyurethane, absorbable polymers, polypropylene, PTFE, e-PTFE, hydro-gel, Titanium mesh, stainless steel mesh, and/or etc.).
- the sheet 24 is a mesh that is fabric knitted from very thin yarn with pores, having 5-20 Wales count/cm, 10-30 course count/cm.
- the material selected for the sheet 24 is such that the sealant 18 can penetrate the material of the sheet 24 to assist in bonding the sheet 24 to a myocardial surface 20 .
- the sheet 24 has micro pores/voids 28 defined between threads/structures 30 forming the porous or mesh material of the sheet 24 .
- the sealant material 18 can impregnate the micro pores/voids 28 in the sheet 24 .
- the sheet 24 is loaded with sealant 18 prior to being delivered through the introducer 32 .
- the sheet 24 is loaded with the sealant 18 according to a defined ratio.
- the sealant 18 is applied to the sheet 24 subsequent to the patch 22 being delivered to the pericardial space 6 . In either case, the sealant 18 impregnates the pores/voids 28 and assists in adhering the patch 22 to the epicardial surface 20 to form the reinforcement 2 over the myocardial infarction 4 .
- the sheet 24 has different surface designs or conditions on its flat faces.
- the sheet-face facing the pericardium will be smooth (e.g., a non-porous structure) and the sheet-face facing the epicardial surface is porous.
- the smooth sheet-face facing the pericardium will mitigate interaction of the pericardium with the sheet 24 to decrease tissue ingrowth from the pericardium.
- the porous sheet-face facing the epicardial surface will facilitate the sealant impregnating the sheet to bond the patch 22 to the epicardial surface.
- FIG. 3 is a diagrammatic plan view of a patient 16 with the chest open to reveal the patch 22 being located intrapericardially via an introducer 32 extending through a percutaneous puncture 12 in the subxiphoid regionl 4 .
- FIGS. 4-7 are diagrammatic views of the patch 22 at various stages of its deployment via the introducer 32 .
- FIG. 8 is a cross section view of the patch 22 as taken along section line 2 - 2 in FIG. 2 , except the patch 22 is deployed in the intrapericardial space 6 and adhered to the epicardial surface 20 via a sealant 18 to form the reinforcement 2 of the myocardial infarction 4 .
- the myocardium infarction 4 may be located via an imaging system (e.g., via an echo-graphic system).
- the pericardium 10 surrounding the heart 7 is accessed via a percutanous puncture 12 in the subxiphoid area 14 of the patient 16 and a puncture 8 in the pericardial sac 10 .
- the punctures 12 , 8 may be made via a Touhy needle viewed under fluoroscopy.
- a guide wire is placed through the central lumen of the Touhy needle into the pericardial space 6 .
- the Touhy needle is withdrawn and an introducer 32 is placed over the guidewire (not shown) into the pericardial space 6 and the distal end 34 of the introducer 32 is positioned near the myocardium infarction 4 .
- the guidewire is removed from within the introducer 32 and, as indicated in FIG. 4 , the patch 22 is positioned near a proximal end 36 of the introducer 32 .
- the introducer 32 extends into the pericardial space 6 via the percutanous puncturel 2 in the subxiphoid area 14 and the pericardial sac puncture 8 such that the distal end 34 of the introducer 32 is positioned near the myocardial infarction 4 of the heart 7 of the patient 16 .
- the patch 22 is collapsed from a deployed or expanded condition (illustrated in FIGS. 1 and 4 ) to a collapsed or non-deployed condition so as to allow the patch 22 to be inserted in the lumen of the introducer sheath 32 .
- a pushing member e.g., a stylet
- FIGS. 5 and 6 a pushing member 38 is displaced distally (as indicated by arrow A) such that a distal end 40 of the stylet 38 contacts and distally moves the collapsed patch 22 through the lumen of the introducer 32 to eventually protrude from the distal end 34 of the introducer 32 .
- the patch 22 which is biased to expand or deploy, expands to the deployed or expanded condition best illustrated in FIGS. 1 and 4 .
- the distal ends 40 , 34 of the stylet 38 and/or introducer 32 are rotated and distally and/or proximally displaced via manipulation of their respective proximal ends 42 , 36 to manipulate the patch 22 into position over the myocardial infarction 4 .
- the fully expanded or deployed patch 22 is placed over the epicardial surface 20 of the infarct 4 such that the sheet 24 extends across the epicardial surface 20 in a plane generally parallel to the epicardial surface 20 .
- the patch 22 is configured to collapse in a direction transverse to the direction of travel through the introducer 32 , thereby allowing the patch 22 to pass through the introducer lumen. Upon exiting the distal end of the introducer lumen, the patch 22 expands transversely back to the expanded state depicted in FIGS. 1 and 4 .
- the patch 22 expands in other manners between the non-deployed and deployed states as illustrated in FIGS. 9 and 10 .
- FIG.9 is a perspective view of a patch 22 in a non-deployed state being passed through a lumen of an introducer 32 .
- FIG. 10 is the same view depicted in FIG. 10 , except the patch 22 has biased into the expanded or deployed state and is being maneuvered into place over a myocardial infarction via a stylet distal end 40 .
- the patch 22 is rolled up and passed through the introducer lumen as a roll.
- the stylet 38 is used to distally push the rolled patch 22 through the introducer lumen.
- the wall of the introducer lumen maintains the patch 22 in the rolled state until the roll exits the introducer distal end 34 to bias into the expanded or deployed state depicted in FIG. 10 .
- the stylet proximal end 42 and/or introducer proximal end 36 are rotated and/or longitudinally displaced to manipulate their respective distal ends 40 , 34 to maneuver the patch 22 into position over the myocardial infarction 4 .
- the patch 22 is loaded with sealant 18 prior to the patch 22 being deployed through the introducer 32 .
- the sealant 18 impregnating the sheet 24 of the patch 22 adheres the underside of the patch 22 to the epicardial surface 20 , thereby forming the reinforcement 2 over the myocardial infarction 4 .
- the sealant 18 is preferably present in the patch 22 in sufficient amounts to adequately bond the patch 22 to the epicardial surface 20 without the application of any other amounts of sealant 18 .
- the medical sealant material 18 is a fibrin sealant, a gelatin-resorcinol-formaldehyde glue, a hydrogel sealant, an alginate, a cyanoacrylate ester, or etc.
- sealant 18 is applied prior to and/or subsequent to the deployment of the patch 22 over the myocardial infarction 4 .
- FIGS. 11 and 12 Such embodiments are illustrated in FIGS. 11 and 12 .
- FIG. 11 is the same view depicted in FIGS. 4-7 , except sealant 18 is being applied prior to the deployment of the patch 22 to the myocardial infarction 4 .
- FIG. 12 is the same view as FIGS. 4-7 , except the sealant 18 is being applied subsequent to the deployment of the patch 22 to the myocardial infarction 4 .
- a distal end 44 of a sealant-dispensing syringe 46 is passed through the introducer lumen to protrude from the introducer distal end 34 .
- Sealant 18 is applied to the epicardial surface 20 at the myocardial infarction 4 via the syringe distal end 44 .
- a patch 22 (not shown) is then deployed over the myocardial infarction 4 and sealant 18 per one of the methods depicted in FIGS. 4-10 .
- the patch 22 is loaded with sealant.
- the sealant 18 applied to the epicardial surface 20 prior to the patch deployment and the sealant carried by the patch 22 combine to provide sufficient adherence of the patch 22 to the epicardial surface 20 over the myocardial infarction 4 to form the reinforcement 2 .
- the patch 22 is not loaded with sealant.
- the sealant 18 applied to the epicardial surface 20 prior to the patch deployment is by itself sufficient to provide sufficient adherence of the patch 22 to the epicardial surface 20 over the myocardial infarction 4 to form the reinforcement 2 .
- sealant 18 is deployed as depicted in FIG. 11 and the patch 22 is deployed as illustrated in FIGS. 4-10 .
- sealant 18 is applied over the outer surface of the patch 22 via the distal end 44 of a sealant dispensing syringe 46 .
- the sealants 18 applied prior and subsequent to the deployment of the patch 22 and the sealant 18 (if any) loaded in the patch 22 combine to sufficiently adhere the patch 22 to the epicardial surface 20 over the myocardial infarction 4 to form the reinforcement 2 .
- the patch 22 is deployed as illustrated in FIGS. 4-10 .
- no sealant 18 is applied to the epicardial surface 20 prior to the deployment of the patch 22 .
- a sealant 18 is applied over the outer surface of the patch 22 .
- the sealant 18 applied subsequent to the patch deployment and the sealant (if any) loaded in the patch 22 combine to sufficiently adhere the patch 22 to the epicardial surface 20 over the myocardial infarction 4 to form the reinforcement 2 .
- the sealant (if any) loaded in the patch 22 and each application of sealant 18 , whether applied prior to or subsequent to the patch deployment, is the same type of sealant, although the sealant may be applied in one or more sealant components, as discussed below.
- the medical sealant material 18 is a fibrin sealant such as CROSSEALTM as manufactured by OMRIX Biopharmaceuticals, Ltd. of Belgium or TISSEELTM as manufactured by Fuer Haemoderivate G.M.B.H. of Vienna, Austria.
- the fibrin sealant 18 is formed from two or more different medical sealant components.
- a first applied sealant component is a solution containing fibrinogen and Factor XIII
- the second applied sealant component is a solution containing thrombin and CaCl 2 .
- the sealant components react.
- the reaction is similar to the final stages of blood clotting and results in polymerization of the fibrinogen to fibrin monomers and a white fibrin clot is initiated under the action of thrombin and CaCl 2 .
- the fibrin sealant material 18 is hemostatic, biodegradable, is associated with excellent tissue tolerance, readily adheres to connective tissue and promotes wound healing.
- the medical sealant material 18 is a cyanoacrylate ester, which is a fluid monomer that polymerizes rapidly in the presence of weak bases such as water or NH 2 groups.
- the cyanoacrylates spread rapidly on the surface of a myocardial infarction 4 and polymerize rapidly in the presence of blood. These materials achieve rapid hemostasis as well as a strong bond to tissue.
- the medical sealant material 18 is gelatin-resorcinol-formaldehyde glue.
- the glue is fabricated by warming a 3:1 mixture of gelatin and resorcinol and adding an 18% formaldehyde solution. Cross-linking of the gelatin and resorcinol by the formaldehyde takes place in about 30 seconds to provide rapid hemostasis and a strong tissue bond.
- the medical sealant material 18 is a polyethylene glycol (“PEG”) hydrogel.
- PEG hydrogel as manufactured by Focal, Inc. of Lexington, Mass., is formed by in situ macromers followed by photopolymerization to highly cross-linked structures. The resulting medical sealant material 18 provides rapid hemostasis and a strong tissue bond.
- the medical sealant material 18 is an alginate.
- the resulting medical sealant material 18 provides rapid hemostasis and a strong tissue bond.
- the medical sealant material 18 is formed via two or more medical sealant components reacted together.
- the medical sealant components 18 may be applied to the myocardial infarction 4 at the same instance or in separate instances.
- a first medical sealant component is a low molecular weight monomer or oligomer
- a second medical sealant component is a catalyst or another reactant.
- the catalyst When the catalyst is combined with the monomer to create the reinforcement 2 , the catalyst causes the monomer to rapidly polymerize.
- the reactant when the reactant is combined with the oligomer to create the reinforcement 2 , the reactant causes the oligomer to rapidly polymerize.
- a first sealant component e.g., a low molecular weight monomer or an oligomer
- the patch 22 (not shown), which is loaded with a second sealant component (e.g., a catalyst or reactant), is then applied to the first sealant component.
- the first and second sealant components react to rapidly polymerize the sealant component, achieving rapid hemostasis and a strong adhesion of the patch 22 and medical sealant to the myocardial infarction 4 , thereby forming the reinforcement 2 .
- a first sealant component e.g., a low molecular weight monomer or an oligomer
- the patch 22 which may or may not be loaded with one of the sealant components
- the second sealant component e.g., a catalyst or reactant
- the first and second sealant components react to rapidly polymerize the sealant component, achieving rapid hemostasis and a strong adhesion of the patch 22 and medical sealant 18 to the myocardial infarction 4 , thereby forming the reinforcement 2 .
- a patch 22 loaded with a first sealant component e.g., a low molecular weight monomer or an oligomer
- a first sealant component e.g., a low molecular weight monomer or an oligomer
- the second sealant component e.g., a catalyst or reactant
- the first and second sealant components react to rapidly polymerize the sealant component, achieving rapid hemostasis and a strong adhesion of the patch 22 and medical sealant 18 to the myocardial infarction 4 , thereby forming the reinforcement 2 .
- the sealant 18 provided at the myocardial infarction 4 prior to the deployment of the patch 22 is formed of a first sealant component (e.g., a low molecular weight monomer or an oligomer) and a second sealant component (e.g., a catalyst or reactant).
- the first and second sealant components are applied via a twin syringe (not shown) immediately prior to the deployment of the patch 22 .
- the first and second sealant components react to achieve rapid hemostasis and a strong adhesion of the patch (not shown) and medical sealant 18 to the myocardial infarction 4 , thereby forming the reinforcement 2 .
- the patch 22 is deployed at the myocardial infarction 4 .
- the sealant 18 provided over the patch at the myocardial infarction 4 subsequent to the deployment of the patch 22 is formed of a first sealant component (e.g., a low molecular weight monomer or an oligomer) and a second sealant component (e.g., a catalyst or reactant).
- the first and second sealant components are applied via a twin syringe (not shown) subsequent to the deployment of the patch 22 .
- the first and second sealant components react to achieve rapid hemostasis and a strong adhesion of the patch 22 and medical sealant 18 to the myocardial infarction 4 , thereby forming the reinforcement 2 .
- the first sealant component is a low molecular weight monomer or an oligomer
- the second sealant component is a catalyst or reactant.
- the first sealant component is a solution containing fibrinogen and Factor XIII
- the second sealant component is a solution containing thrombin and CaCl 2 .
- the first sealant component is a solution containing a 3:1 mixture of gelatin and resorcinol
- the second sealant component is a solution of 18% formaldehyde.
- sealant components reacting to form a sealant material 18
- the sealant components may be applied or provided in combinations and sequences other than those examples provided above. Such other combinations and sequences should be considered within the scope of this Detailed Description.
- the fixing time of the patch 22 to the epicardial surface can be controlled by the mixing ratio of the sealant components.
- the time for the sealant material to cure and affix or form the patch over the infarction can be increased or decreased depending on the mixing ratio of a first sealant component relative to the other sealant component(s) forming the sealant material.
- first and second tubes 48 , 49 leading from twin separate nozzles of a twin chamber syringe 52 are fed through the introducer 32 such that the tube distal ends 48 ′, 49 ′ protrude from the introducer 32 near the myocardial infarction 4 .
- FIG. 13 and 14 which are views similar to FIGS. 11 and 12 .
- a first plunger 56 is distally displaced within the syringe 52 to dispense through the first tube 48 any one of the above-discussed first sealant components 18 ′ (e.g., a solution of fibrinogen and XIII) onto the epicardial surface 20 of the myocardial infarction 4 .
- a second plunger 58 is distally displaced within the syringe 52 to dispense through the second tube 49 onto the first sealant component 18 ′ any one of the above-discussed second sealant components 18 ′′ (e.g., a solution of thrombin and CaCl 2 ) compatible with the applied first sealant component 18 ′.
- the first and second sealant components 18 ′, 18 ′′ react to rapidly polymerize into the sealant 18 , which strongly adheres to the heart tissue and achieves rapid hemostasis.
- the sealant 18 dispensed on the myocardial infarction 4 forms the reinforcement 2 , which does not employ a patch 22 .
- twin syringe 52 and the first and second sealant components 18 ′, 18 ′′ are the same as discussed with respect to FIGS. 13 and 14 , except the syringe 52 has a single mixing nozzle and a single dispensing tube extending from the mixing nozzle.
- the single dispensing tube extends through the introducer 32 to the myocardial infarction 4 .
- Both plungers 56 , 58 are distally displaced together within the syringe 52 , causing the first and second sealant components 18 ′, 18 ′′ to mix in the mixing nozzle and be dispensed as a mixed sealant material 18 onto the myocardial infarction 4 .
- the mixed sealant material 18 forms the reinforcement, which does not employ a patch 22 .
- the reinforcement 2 is advantageous for a number of reasons.
- the reinforcement 2 mechanically constrains the heart tissue at the myocardial infarction 4 , thereby preventing, or at least reducing, dilation of the left ventricle by supporting and thickening the area that has been thinned due to the myocardial infarction scar. Preventing the dilation of the left ventricle may prevent, or at least mitigate, left ventricle remodeling that can eventually lead to heart failure in post myocardial infarction patients.
Abstract
A method of treating a heart condition includes dispensing first and second sealant components to a myocardial infarction via an introducer extending through a percutaneous puncture in a subxiphoid region. The first and second sealant components combine to form a medical sealant material that bonds to the myocardial infarction to form a reinforcement for the myocardial infarction, wherein the reinforcement does not include a patch.
Description
- This application is a division of copending U.S. patent application Ser. No. 11/735,192, filed Apr. 13, 2007, titled “Sutureless Reinforcement For and Method Of Treating a Myocardial Infarction.”
- The invention relates generally to medical apparatus and methods and more specifically, to reinforcements for myocardial infarctions and methods of forming such reinforcements.
- A myocardial infarction is the irreversible damage done to a segment of heart muscle by ischemia, where the myocardium is deprived of adequate oxygen and metabolite removal due to an interruption in blood supply. Ischemia is usually due to a sudden thrombotic occlusion of a coronary artery, commonly called a heart attack.
- If the coronary artery becomes completely occluded and there is poor collateral blood flow to the affected area, an infarction can result. In some cases, the resulting infarction will be a transmural or full-wall thickness infarct in which much of the contractile function of the area is lost. Over a period of one to two months, the necrotic tissue heals, leaving a scar. The most extreme example of this is a ventricular aneurysm where all of the muscle fibers in the area are destroyed and replaced by fibrous scar tissue.
- Even if the ventricular dysfunction as a result of the infarct is not immediately life threatening, common sequelae of a myocardial infarction in the left ventricle, whether the infarction is transmural or not, include mechanical cardiac disorders (e.g., heart remodeling such as ventricular remodeling or ventricular rupture) and electrical cardiac disorders. Such cardiac disorders lead to congestive heart failure where cardiac output falls below a level adequate to meet the metabolic needs of the body which, if uncompensated, leads to rapid death.
- With respect to heart remodeling, whether the infarction is transmural or not, the damaged heart tissue may begin a long slow process of thinning and localized remodeling. Since the myocardial tissue is damaged and usually inadequately perfused, the damaged tissue contributes less to overall heart function compared to when the tissue was undamaged. The localized remodeling tends to place a greater demand on the rest of the heart to compensate for the reduced contractile capability of the damaged tissue. As a result, global heart function may be affected and, ultimately, the patient may experience global heart remodeling and descend into heart failure.
- It is believed that preventing localized heart remodeling and the often-resulting globalized heart remodeling can prevent heart failure. Placing patches or substrates over the myocardial infarction is an emerging therapy believed to prevent localized heart remodeling and, as a result, global heart remodeling. The patches or substrates are used to reinforce the infarction and prevent the infarction from relaxing and expanding as time passes.
- Such patches or substrates are implanted via highly invasive open chest procedures and are sutured or stapled to the infarct tissue or tissue adjacent to the infarct. Highly invasive open chest procedures significantly increase patient risk and recovery time. Also, infarct tissue or tissue adjacent to the infarct is often too fragile to receive sutures or staples.
- There is a need in the art for a myocardial infarct reinforcement that does not require suturing/stapling. There is also a need for such a reinforcement that can be delivered via a minimally invasive procedure. There is also a need in the art for a method of treating a myocardial infarct that does not require suturing/stapling. There is also a need in the art for such a method that is minimally invasive.
- Briefly, and in general terms, the invention relates to methods of treating myocardial infarction. One such method includes assembling a myocardial infarction reinforcement at a location of a myocardial infarction in a patient.
- Another method of treating myocardial infarction includes impregnating a patch with a first sealant component; delivering the patch to a myocardial infarction via an introducer extending through a percutaneous puncture in a subxiphoid region of a patient; and delivering a second sealant component to the myocardial infarction via the introducer extending through the percutaneous puncture in the subxiphoid region, wherein the first and second components combine to form a medical sealant material that bonds the patch to the myocardial infarction, thereby forming a reinforcement for the myocardial infarction.
- Yet another method of treating myocardial infarction includes dispensing first and second sealant components to a myocardial infarction via an introducer extending through a percutaneous puncture in a subxiphoid region, the first and second sealant components combine to form a medical sealant material that bonds to the myocardial infarction to form a reinforcement for the myocardial infarction, wherein the reinforcement does not include a patch.
- The invention also relates to myocardial infarction reinforcements. One such reinforcement includes a patch and medical sealant material. The patch includes a sheet having pores/voids. The patch extends over a myocardial infarction. The medical sealant material impregnates the pores/voids and bonds the patch to the myocardial infarction.
- Another reinforcement includes a medical sealant material extending over and bonding to a myocardial infarction to form the reinforcement.
- While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
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FIG. 1 is a plan view of a patch used to form a myocardial infarction reinforcement. -
FIG. 2 is a cross section of the patch as taken along section line 2-2 inFIG. 1 . -
FIG. 3 is a diagrammatic plan view of a patient with the chest open to reveal the patch being located intrapericardially via an introducer extending through a percutaneous puncture in the subxiphoid region. -
FIGS. 4-7 are diagrammatic views of the patch at various stages of its deployment via the introducer. -
FIG. 8 is a cross section view of the patch as taken along section line 2-2 inFIG. 2 , except the patch is deployed in the intrapericardial space and adhered to the epicardial surface via the sealant to form the reinforcement of the myocardial infarction. -
FIG. 9 is a perspective view of a patch in a non-deployed state being passed through a lumen of an introducer. -
FIG. 10 is the same view depicted inFIG. 9 , except the patch has biased into the expanded or deployed state and is being maneuvered into place over a myocardial infarction via a stylet distal end. -
FIG. 11 is the same view depicted inFIGS. 4-7 , except sealant is being applied prior to the deployment of the patch to themyocardial infarction 4. -
FIG. 12 is the same view asFIGS. 4-7 , except the sealant is being applied subsequent to the deployment of the patch to the myocardial infarction. -
FIGS. 13 and 14 are views similar toFIGS. 11 and 12 , except illustrating a creation of a myocardial infarction reinforcement that does not employ a patch. - The present application describes suture-free/staple-free reinforcements for, and methods of, treating a myocardial infarction that is leading to, or already has lead to, ventricular remodel or rupture. The reinforcements can be delivered and the treatment method can be performed by open chest procedures or, advantageously, by minimally invasive procedures such as accessing the intrapericardial space surrounding the heart via a puncture in the pericardial sac and a percutaneous puncture in the subxiphoid region of a patient.
- In one embodiment, the reinforcement is one or more layers of medical adhesive and/or sealant material (generically referred to in the rest of this Detailed Description as medical sealant material) directly applied to the epicardial surface of a myocardial infarction. In other embodiments, the reinforcement is a patch adhered to the epicardial surface of a myocardial infarction via the sealant material. The sealant material can impregnate the patch and/or be applied prior to, during, and/or subsequent to the patch being located over the myocardial infarction. Regardless of whether the reinforcement is formed via a patch/sealant combination or solely with sealant, the reinforcement adheres to and reinforces the myocardial infarction without the use of sutures or staples. Also, for some embodiments, the reinforcement can be said to be formed, assembled or created in the patient at the location of the myocardial infarction.
- With reference to
FIGS. 1-3 , in one embodiment, thepatch 22 includes aframe 26 and a mesh orporous sheet 24 extending between sides or sections of theframe 26. In other embodiments, thepatch 22 will not include aframe 26, but will simply be thesheet 24. - The
sheet 24 may be attached to one side of theframe 26. Alternatively, thesheet 24 extends about the frame 26 (e.g., theframe 26 is received in a seam of the sheet 24). The size of thesheet 24 may be generally the same as the size of theframe 26 or it may exceed the size of theframe 26 such that the edge of thesheet 24 extends past theframe 26. - Sizes of the
patch 22 in their respective deployed, flattened states vary depending on the size of the heart 7 and the size of theinfarcted area 4. In one configuration, thepatch 22 in its deployed, flattened state is at least approximately four millimeters by at least approximately seven millimeters. In another configuration, thepatch 22 in its deployed, flattened state has a diameter of between approximately five millimeters and approximately eight millimeters. With respect to thickness, in one configuration, thepatch 22 it its deployed, flattened state has a thickness of between approximately 0.2 millimeters and approximately 0.5 millimeters, while in another configuration it has a thickness of between approximately 0.1 millimeters and approximately 2 millimeters. - The
patch 22 in its deployed, flattened state is preferably at least approximately the same size as the area of the myocardial infarction. In one embodiment, thepatch 22 in its deployed, flattened state has a size that exceeds the size of the area of the myocardial infarction by approximately zero percent to approximately 20 percent or more. - The
sheet 24 is fixed to theframe 26 via molding, gluing, suturing, or welding (e.g., sonic, chemical, heat, laser, etc.). Theframe 26 may be formed of Nitinol, polytetrafluoroethylene (“PTFE”), silicone rubber, polyurethane, etc. Thesheet 24 may be formed of a mesh or porous biocompatible natural material (e.g., a sheet of pericardium, etc.) or a mesh or porous biocompatible synthetic material (e.g., DACRON®, polyester, polyurethane, absorbable polymers, polypropylene, PTFE, e-PTFE, hydro-gel, Titanium mesh, stainless steel mesh, and/or etc.). In one embodiment, thesheet 24 is a mesh that is fabric knitted from very thin yarn with pores, having 5-20 Wales count/cm, 10-30 course count/cm. - Regardless of the material selected for the
sheet 24, in one embodiment, the material selected for thesheet 24 is such that thesealant 18 can penetrate the material of thesheet 24 to assist in bonding thesheet 24 to amyocardial surface 20. For example, as indicated inFIG. 2 , in one embodiment, thesheet 24 has micro pores/voids 28 defined between threads/structures 30 forming the porous or mesh material of thesheet 24. Thus, thesealant material 18 can impregnate the micro pores/voids 28 in thesheet 24. - In one embodiment, the
sheet 24 is loaded withsealant 18 prior to being delivered through theintroducer 32. Thesheet 24 is loaded with thesealant 18 according to a defined ratio. In other embodiments, thesealant 18 is applied to thesheet 24 subsequent to thepatch 22 being delivered to thepericardial space 6. In either case, thesealant 18 impregnates the pores/voids 28 and assists in adhering thepatch 22 to theepicardial surface 20 to form thereinforcement 2 over themyocardial infarction 4. - In one embodiment, the
sheet 24 has different surface designs or conditions on its flat faces. For example, in one embodiment, the sheet-face facing the pericardium will be smooth (e.g., a non-porous structure) and the sheet-face facing the epicardial surface is porous. The smooth sheet-face facing the pericardium will mitigate interaction of the pericardium with thesheet 24 to decrease tissue ingrowth from the pericardium. The porous sheet-face facing the epicardial surface will facilitate the sealant impregnating the sheet to bond thepatch 22 to the epicardial surface. - For a detailed discussion of a method of deploying the
patch 22 to form areinforcement 2 over amyocardial infarction 4, reference is made toFIGS. 3-8 .FIG. 3 is a diagrammatic plan view of a patient 16 with the chest open to reveal thepatch 22 being located intrapericardially via anintroducer 32 extending through apercutaneous puncture 12 in the subxiphoid regionl4.FIGS. 4-7 are diagrammatic views of thepatch 22 at various stages of its deployment via theintroducer 32.FIG. 8 is a cross section view of thepatch 22 as taken along section line 2-2 inFIG. 2 , except thepatch 22 is deployed in theintrapericardial space 6 and adhered to theepicardial surface 20 via asealant 18 to form thereinforcement 2 of themyocardial infarction 4. - The
myocardium infarction 4 may be located via an imaging system (e.g., via an echo-graphic system). As can be understood fromFIG. 3 , thepericardium 10 surrounding the heart 7 is accessed via apercutanous puncture 12 in thesubxiphoid area 14 of thepatient 16 and apuncture 8 in thepericardial sac 10. Thepunctures pericardial space 6. The Touhy needle is withdrawn and anintroducer 32 is placed over the guidewire (not shown) into thepericardial space 6 and thedistal end 34 of theintroducer 32 is positioned near themyocardium infarction 4. - The guidewire is removed from within the
introducer 32 and, as indicated inFIG. 4 , thepatch 22 is positioned near aproximal end 36 of theintroducer 32. Theintroducer 32 extends into thepericardial space 6 via the percutanous puncturel2 in thesubxiphoid area 14 and thepericardial sac puncture 8 such that thedistal end 34 of theintroducer 32 is positioned near themyocardial infarction 4 of the heart 7 of thepatient 16. - As depicted in
FIG. 5 , thepatch 22 is collapsed from a deployed or expanded condition (illustrated inFIGS. 1 and 4 ) to a collapsed or non-deployed condition so as to allow thepatch 22 to be inserted in the lumen of theintroducer sheath 32. As can be understood fromFIGS. 5 and 6 , a pushing member (e.g., a stylet) 38 is displaced distally (as indicated by arrow A) such that adistal end 40 of thestylet 38 contacts and distally moves thecollapsed patch 22 through the lumen of theintroducer 32 to eventually protrude from thedistal end 34 of theintroducer 32. As indicated inFIG. 7 , once thepatch 22 fully emerges from the lumen of the introducerdistal end 34, thepatch 22, which is biased to expand or deploy, expands to the deployed or expanded condition best illustrated inFIGS. 1 and 4 . As indicated by arrows B, C, D and E, the distal ends 40, 34 of thestylet 38 and/orintroducer 32 are rotated and distally and/or proximally displaced via manipulation of their respective proximal ends 42, 36 to manipulate thepatch 22 into position over themyocardial infarction 4. - As can be understood from
FIGS. 7 and 8 , the fully expanded or deployedpatch 22 is placed over theepicardial surface 20 of theinfarct 4 such that thesheet 24 extends across theepicardial surface 20 in a plane generally parallel to theepicardial surface 20. As can be understood fromFIGS. 4-6 , in one embodiment, thepatch 22 is configured to collapse in a direction transverse to the direction of travel through theintroducer 32, thereby allowing thepatch 22 to pass through the introducer lumen. Upon exiting the distal end of the introducer lumen, thepatch 22 expands transversely back to the expanded state depicted inFIGS. 1 and 4 . - In other embodiments, the
patch 22 expands in other manners between the non-deployed and deployed states as illustrated inFIGS. 9 and 10 .FIG.9 is a perspective view of apatch 22 in a non-deployed state being passed through a lumen of anintroducer 32.FIG. 10 is the same view depicted inFIG. 10 , except thepatch 22 has biased into the expanded or deployed state and is being maneuvered into place over a myocardial infarction via a styletdistal end 40. - As shown in
FIG. 9 , thepatch 22 is rolled up and passed through the introducer lumen as a roll. As indicated by arrow A, thestylet 38 is used to distally push the rolledpatch 22 through the introducer lumen. The wall of the introducer lumen maintains thepatch 22 in the rolled state until the roll exits the introducerdistal end 34 to bias into the expanded or deployed state depicted inFIG. 10 . As indicated by arrows B, C, D, and E, the styletproximal end 42 and/or introducerproximal end 36 are rotated and/or longitudinally displaced to manipulate their respective distal ends 40, 34 to maneuver thepatch 22 into position over themyocardial infarction 4. - Regardless of whether the patch deployment configuration is as depicted in
FIGS. 4-7 orFIGS. 9-10 , in one embodiment, thepatch 22 is loaded withsealant 18 prior to thepatch 22 being deployed through theintroducer 32. Thesealant 18 impregnating thesheet 24 of thepatch 22 adheres the underside of thepatch 22 to theepicardial surface 20, thereby forming thereinforcement 2 over themyocardial infarction 4. Thesealant 18 is preferably present in thepatch 22 in sufficient amounts to adequately bond thepatch 22 to theepicardial surface 20 without the application of any other amounts ofsealant 18. In one such embodiment, themedical sealant material 18 is a fibrin sealant, a gelatin-resorcinol-formaldehyde glue, a hydrogel sealant, an alginate, a cyanoacrylate ester, or etc. - In some embodiments,
sealant 18 is applied prior to and/or subsequent to the deployment of thepatch 22 over themyocardial infarction 4. Such embodiments are illustrated inFIGS. 11 and 12 .FIG. 11 is the same view depicted inFIGS. 4-7 , exceptsealant 18 is being applied prior to the deployment of thepatch 22 to themyocardial infarction 4.FIG. 12 is the same view asFIGS. 4-7 , except thesealant 18 is being applied subsequent to the deployment of thepatch 22 to themyocardial infarction 4. - As shown in
FIG. 11 , adistal end 44 of a sealant-dispensingsyringe 46 is passed through the introducer lumen to protrude from the introducerdistal end 34.Sealant 18 is applied to theepicardial surface 20 at themyocardial infarction 4 via the syringedistal end 44. A patch 22 (not shown) is then deployed over themyocardial infarction 4 andsealant 18 per one of the methods depicted inFIGS. 4-10 . - In one embodiment, the
patch 22 is loaded with sealant. Thesealant 18 applied to theepicardial surface 20 prior to the patch deployment and the sealant carried by thepatch 22 combine to provide sufficient adherence of thepatch 22 to theepicardial surface 20 over themyocardial infarction 4 to form thereinforcement 2. - In another embodiment, the
patch 22 is not loaded with sealant. Thesealant 18 applied to theepicardial surface 20 prior to the patch deployment is by itself sufficient to provide sufficient adherence of thepatch 22 to theepicardial surface 20 over themyocardial infarction 4 to form thereinforcement 2. - In alternative versions of either of the two immediately preceding embodiments, once a
sealant 18 is deployed as depicted inFIG. 11 and thepatch 22 is deployed as illustrated inFIGS. 4-10 ,sealant 18 is applied over the outer surface of thepatch 22 via thedistal end 44 of asealant dispensing syringe 46. Thesealants 18 applied prior and subsequent to the deployment of thepatch 22 and the sealant 18 (if any) loaded in thepatch 22 combine to sufficiently adhere thepatch 22 to theepicardial surface 20 over themyocardial infarction 4 to form thereinforcement 2. - With reference to
FIG. 12 , in one embodiment, thepatch 22 is deployed as illustrated inFIGS. 4-10 . However, unlike the immediately preceding embodiments discussed with reference toFIG. 11 , nosealant 18 is applied to theepicardial surface 20 prior to the deployment of thepatch 22. Once thepatch 22 is deployed, asealant 18 is applied over the outer surface of thepatch 22. Thesealant 18 applied subsequent to the patch deployment and the sealant (if any) loaded in thepatch 22 combine to sufficiently adhere thepatch 22 to theepicardial surface 20 over themyocardial infarction 4 to form thereinforcement 2. - In one embodiment, the sealant (if any) loaded in the
patch 22 and each application ofsealant 18, whether applied prior to or subsequent to the patch deployment, is the same type of sealant, although the sealant may be applied in one or more sealant components, as discussed below. - In one embodiment, the
medical sealant material 18 is a fibrin sealant such as CROSSEAL™ as manufactured by OMRIX Biopharmaceuticals, Ltd. of Belgium or TISSEEL™ as manufactured by Fuer Haemoderivate G.M.B.H. of Vienna, Austria. In one embodiment as discussed below, thefibrin sealant 18 is formed from two or more different medical sealant components. For example, a first applied sealant component is a solution containing fibrinogen and Factor XIII, and the second applied sealant component is a solution containing thrombin and CaCl2. On mixing the two sealant components using a device such as a twin syringe with a mixing nozzle, the sealant components react. The reaction is similar to the final stages of blood clotting and results in polymerization of the fibrinogen to fibrin monomers and a white fibrin clot is initiated under the action of thrombin and CaCl2. Thefibrin sealant material 18 is hemostatic, biodegradable, is associated with excellent tissue tolerance, readily adheres to connective tissue and promotes wound healing. - In another embodiment, the
medical sealant material 18 is a cyanoacrylate ester, which is a fluid monomer that polymerizes rapidly in the presence of weak bases such as water or NH2 groups. The cyanoacrylates spread rapidly on the surface of amyocardial infarction 4 and polymerize rapidly in the presence of blood. These materials achieve rapid hemostasis as well as a strong bond to tissue. - In another embodiment, the
medical sealant material 18 is gelatin-resorcinol-formaldehyde glue. The glue is fabricated by warming a 3:1 mixture of gelatin and resorcinol and adding an 18% formaldehyde solution. Cross-linking of the gelatin and resorcinol by the formaldehyde takes place in about 30 seconds to provide rapid hemostasis and a strong tissue bond. - In yet another embodiment, the
medical sealant material 18 is a polyethylene glycol (“PEG”) hydrogel. A PEG hydrogel, as manufactured by Focal, Inc. of Lexington, Mass., is formed by in situ macromers followed by photopolymerization to highly cross-linked structures. The resultingmedical sealant material 18 provides rapid hemostasis and a strong tissue bond. - In still another embodiment, the
medical sealant material 18 is an alginate. The resultingmedical sealant material 18 provides rapid hemostasis and a strong tissue bond. - As mentioned above, in some embodiments, the
medical sealant material 18 is formed via two or more medical sealant components reacted together. Themedical sealant components 18 may be applied to themyocardial infarction 4 at the same instance or in separate instances. For example, in one embodiment, a first medical sealant component is a low molecular weight monomer or oligomer, and a second medical sealant component is a catalyst or another reactant. When the catalyst is combined with the monomer to create thereinforcement 2, the catalyst causes the monomer to rapidly polymerize. Similarly, when the reactant is combined with the oligomer to create thereinforcement 2, the reactant causes the oligomer to rapidly polymerize. - As can be understood from
FIG. 11 , in one embodiment of a two-componentmedical sealant material 18, a first sealant component (e.g., a low molecular weight monomer or an oligomer) is first provided at themyocardial infarction 4. The patch 22 (not shown), which is loaded with a second sealant component (e.g., a catalyst or reactant), is then applied to the first sealant component. The first and second sealant components react to rapidly polymerize the sealant component, achieving rapid hemostasis and a strong adhesion of thepatch 22 and medical sealant to themyocardial infarction 4, thereby forming thereinforcement 2. - In another embodiment of a two component
medical sealant material 18, a first sealant component (e.g., a low molecular weight monomer or an oligomer) is first provided at themyocardial infarction 4. Thepatch 22, which may or may not be loaded with one of the sealant components) is then applied to themyocardial infarction 4. The second sealant component (e.g., a catalyst or reactant) is then applied to thepatch 22 and first sealant component. The first and second sealant components react to rapidly polymerize the sealant component, achieving rapid hemostasis and a strong adhesion of thepatch 22 andmedical sealant 18 to themyocardial infarction 4, thereby forming thereinforcement 2. - As can be understood from
FIG. 12 , in yet another embodiment of a two component medical sealant material, apatch 22 loaded with a first sealant component (e.g., a low molecular weight monomer or an oligomer) is first provided at themyocardial infarction 4. The second sealant component (e.g., a catalyst or reactant) is then applied to thepatch 22 and the first sealant component carried by thepatch 22. The first and second sealant components react to rapidly polymerize the sealant component, achieving rapid hemostasis and a strong adhesion of thepatch 22 andmedical sealant 18 to themyocardial infarction 4, thereby forming thereinforcement 2. - As best understood with reference to
FIG. 11 , in one embodiment, thesealant 18 provided at themyocardial infarction 4 prior to the deployment of thepatch 22 is formed of a first sealant component (e.g., a low molecular weight monomer or an oligomer) and a second sealant component (e.g., a catalyst or reactant). The first and second sealant components are applied via a twin syringe (not shown) immediately prior to the deployment of thepatch 22. The first and second sealant components react to achieve rapid hemostasis and a strong adhesion of the patch (not shown) andmedical sealant 18 to themyocardial infarction 4, thereby forming thereinforcement 2. - As best understood with reference to
FIG. 12 , in one embodiment, thepatch 22 is deployed at themyocardial infarction 4. Thesealant 18 provided over the patch at themyocardial infarction 4 subsequent to the deployment of thepatch 22 is formed of a first sealant component (e.g., a low molecular weight monomer or an oligomer) and a second sealant component (e.g., a catalyst or reactant). The first and second sealant components are applied via a twin syringe (not shown) subsequent to the deployment of thepatch 22. The first and second sealant components react to achieve rapid hemostasis and a strong adhesion of thepatch 22 andmedical sealant 18 to themyocardial infarction 4, thereby forming thereinforcement 2. - In a first version of any one of the immediately preceding embodiments, the first sealant component is a low molecular weight monomer or an oligomer, and the second sealant component is a catalyst or reactant. In second version of any one of the immediately preceding embodiments, the first sealant component is a solution containing fibrinogen and Factor XIII, and the second sealant component is a solution containing thrombin and CaCl2. In a third version of any one of the immediately preceding embodiments, the first sealant component is a solution containing a 3:1 mixture of gelatin and resorcinol, and the second sealant component is a solution of 18% formaldehyde.
- While each of the immediately preceding embodiments is discussed in the context of two sealant components reacting to form a
sealant material 18, in other embodiments, there may be more than two sealant components reacting to form a sealant material. Also, the sealant components may be applied or provided in combinations and sequences other than those examples provided above. Such other combinations and sequences should be considered within the scope of this Detailed Description. - For any of the preceding and following embodiments employing a
sealant material 18 formed of multiple sealant components, the fixing time of thepatch 22 to the epicardial surface can be controlled by the mixing ratio of the sealant components. In other words, the time for the sealant material to cure and affix or form the patch over the infarction can be increased or decreased depending on the mixing ratio of a first sealant component relative to the other sealant component(s) forming the sealant material. - While the preceding embodiments employ a
patch 22 in the formation of thereinforcement 2 for the myocardial infarction, in other embodiments thereinforcement 2 will be formed without apatch 22. For example, as depicted inFIGS. 13 and 14 , which are views similar toFIGS. 11 and 12 , first andsecond tubes twin chamber syringe 52 are fed through theintroducer 32 such that the tube distal ends 48′, 49′ protrude from theintroducer 32 near themyocardial infarction 4. As shown inFIG. 13 , afirst plunger 56 is distally displaced within thesyringe 52 to dispense through thefirst tube 48 any one of the above-discussedfirst sealant components 18′ (e.g., a solution of fibrinogen and XIII) onto theepicardial surface 20 of themyocardial infarction 4. As illustrated inFIG. 14 , asecond plunger 58 is distally displaced within thesyringe 52 to dispense through thesecond tube 49 onto thefirst sealant component 18′ any one of the above-discussedsecond sealant components 18″ (e.g., a solution of thrombin and CaCl2) compatible with the appliedfirst sealant component 18′. The first andsecond sealant components 18′, 18″ react to rapidly polymerize into thesealant 18, which strongly adheres to the heart tissue and achieves rapid hemostasis. Thesealant 18 dispensed on themyocardial infarction 4 forms thereinforcement 2, which does not employ apatch 22. - In another embodiment, the
twin syringe 52 and the first andsecond sealant components 18′, 18″ are the same as discussed with respect toFIGS. 13 and 14 , except thesyringe 52 has a single mixing nozzle and a single dispensing tube extending from the mixing nozzle. The single dispensing tube extends through theintroducer 32 to themyocardial infarction 4. Bothplungers syringe 52, causing the first andsecond sealant components 18′, 18″ to mix in the mixing nozzle and be dispensed as amixed sealant material 18 onto themyocardial infarction 4. Themixed sealant material 18 forms the reinforcement, which does not employ apatch 22. - Regardless of whether the
reinforcement 2 is formed of a combination ofpatch 22 andmedical sealant material 18 or solely of amedical sealant 18, thereinforcement 2 is advantageous for a number of reasons. First, although thereinforcement 2 can be applied to amyocardial infarction 4 via an open chest procedure, it is can be advantageously performed via a minimally invasive procedure such as apercutaneous puncture 12 in thesubxiphoid region 14 of apatient 16. Second, thereinforcement 2 affixes to theepicardial surface 20 of or near amyocardial infarction 4 via the adhesive qualities of the medical adhesive orsealant 18 used to form the reinforcement, thereby avoiding the need for sutures/staples and the issues associated therewith. Third, thereinforcement 2 mechanically constrains the heart tissue at themyocardial infarction 4, thereby preventing, or at least reducing, dilation of the left ventricle by supporting and thickening the area that has been thinned due to the myocardial infarction scar. Preventing the dilation of the left ventricle may prevent, or at least mitigate, left ventricle remodeling that can eventually lead to heart failure in post myocardial infarction patients. - Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
Claims (17)
1. A method of treating a heart condition, the method comprising assembling a myocardial infarction reinforcement at a location of a myocardial infarction in a patient, wherein the reinforcement does not include a patch.
2. The method of claim 1 , wherein the reinforcement is assembled by applying a medical sealant material to the myocardial infarction.
3. The method of claim 2 , wherein the medical sealant is formed from a first sealant component combined with a second sealant component.
4. The method of claim 3 , wherein the combining of the components occurs at the location of the myocardial infarction.
5. The method of claim 3 , wherein the combining of the components occurs outside the patient and the combined components are then delivered to the myocardial infarction to assemble the reinforcement.
6. The method of claim 3 , wherein the first sealant component is a low molecular weight monomer or oligomer, and the second sealant component is a catalyst or reactant.
7. The method of claim 3 , wherein the first sealant component is a solution containing fibrinogen and factor XIII, and the second sealant component is a solution containing thrombin and CaCl2.
8. The method of claim 3 , wherein the first sealant contains gelatin and resorcinol, and the second sealant contains formaldehyde.
9. The method of claim 2 , wherein the medical sealant material comprises one of a cyanoacrylate ester, a fibrin sealant, a gelatin-resorcinol-formaldehyde glue, an alginate and a hydrogel sealant.
10. A method of treating a heart condition comprising dispensing first and second sealant components to a myocardial infarction via an introducer extending through a percutaneous puncture in a subxiphoid region, the first and second sealant components combining to form a medical sealant material that bonds to the myocardial infarction to form a reinforcement for the myocardial infarction, wherein the reinforcement does not include a patch.
11. The method of claim 10 wherein the first sealant is dispensed first and the second sealant is dispensed onto the first sealant.
12. A myocardial infarction reinforcement consisting of a medical sealant material configured to extend over and bond to a myocardial infarction to form the reinforcement.
13. The reinforcement of claim 12 , wherein the medical sealant is formed from a first sealant component combined with a second sealant component.
14. The reinforcement of claim 13 , wherein the first sealant component is a low molecular weight monomer or oligomer, and the second sealant component is a catalyst or reactant.
15. The reinforcement of claim 13 , wherein the first sealant component is a solution containing fibrinogen and factor XIII, and the second sealant component is a solution containing thrombin and CaCl2.
16. The reinforcement of claim 13 , wherein the first sealant contains gelatin and resorcinol, and the second sealant contains formaldehyde.
17. The reinforcement of claim 12 , wherein the medical sealant material comprises one of a cyanoacrylate ester, a fibrin sealant, a gelatin-resorcinol-formaldehyde glue, an alginate and a hydrogel sealant.
Priority Applications (1)
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US12/908,662 US20110034954A1 (en) | 2007-04-13 | 2010-10-20 | Sutureless reinforcement for and method of treating a myocardial infarction |
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US73519207A | 2007-04-13 | 2007-04-13 | |
US12/908,662 US20110034954A1 (en) | 2007-04-13 | 2010-10-20 | Sutureless reinforcement for and method of treating a myocardial infarction |
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US73519207A Division | 2007-04-13 | 2007-04-13 |
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US12/908,662 Abandoned US20110034954A1 (en) | 2007-04-13 | 2010-10-20 | Sutureless reinforcement for and method of treating a myocardial infarction |
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